Senior Clinical Research Associate
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What you'll do
- Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations. Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
- Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
- Review CRFs (electronic or paper) and subject source documentation for validity and accuracy
- Verify proper management and accountability of Investigational Product
- Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
- Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
- Timely delivering site documents to eTMF or paper TMF.
- Verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.
- Update CTMS and all other required by projects systems with accurate site level information
- Participate in audit and/or inspection, it’s preparation and follow-up activities, as needed.
- Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.
- May assist the Clinical Research Manager or Project Manager in certain aspects of project activities which may include: project tracking, monitoring plans, Review of monitoring reports, CRA resources management within the project
What they're looking for
- Bachelor’s Degree, preferably in life science or nursing; or equivalent
- >5 years of independent on-site monitoring experience and at least 1 year experience as an unmasked monitor is required.
- Able to work in a fast-paced environment with changing priorities.
- Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
- Possess the understanding of Good Clinical Practice regulations, ICH guidelines.
- Ability to work independently as well as in a team matrix organization.
- Excellent written and verbal communication skills
- Fluent in English and local language
- Excellent organizational skills
- Technology savvy and good software and computer skills
- Ability to take the ownership of the assigned tasks.
- Ability to manage complex or early phases studies.
Nice to have
- At least 1 year Ophthalmology, ideally within a retina indication (i.e. Age-related Macular Degeneration, Diabetic Macular Edema, Geographic Atrophy, RVO, BRVO, CRVO, etc.), experience is preferred.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
Join Our Team as a Freelance Senior Clinical Research Associate (0.1 FTE) - home based in Denmark.
Interested in future opportunities with TFS HealthScience?
We are currently building a network of experienced Freelance Senior Clinical Research Associates for an anticipated ophthalmology project. While this position is not yet actively open for immediate recruitment / onboarding, we encourage interested candidates to apply and join our talent community. Once sponsor requirements are confirmed, our Talent Acquisition Team we will reach out to candidates whose experience best aligns with the project needs.
About this role
As part of our Ophthalmology team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Freelance Senior Clinical Research Associate is part of Clinical Development Services (CDS) within TFS HealthScience, will function operationally as a member of a Project Team and is responsible for the initiation, on-site and/or remote monitoring and close out of study sites during study conduct, according to company policies, SOPs and regulatory requirements.
The Freelance Senior Clinical Research Associate will provide Unmasked Clinical Research Associate support for assigned clinical studies, including management of investigational product accountability, oversight of unblinded site activities, and monitoring of protocol compliance in accordance with study requirements and applicable regulations. The Freelance Senior Clinical Research Associate will collaborate with study teams, investigative sites and sponsors to ensure timely execution of study deliverables while maintaining the integrity of study blinding and data quality.
Key Responsibilities:
Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations. Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
Review CRFs (electronic or paper) and subject source documentation for validity and accuracy
Verify proper management and accountability of Investigational Product
Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
Timely delivering site documents to eTMF or paper TMF.
Verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.
Update CTMS and all other required by projects systems with accurate site level information
Participate in audit and/or inspection, it’s preparation and follow-up activities, as needed.
Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.
May assist the Clinical Research Manager or Project Manager in certain aspects of project activities which may include:
project tracking,
monitoring plans,
Review of monitoring reports
CRA resources management within the project
May perform Assessment Site Visits (ASV) when requested.
May act as a mentor to CRAs.
May develop and implement therapeutic area training for other CRAs and project team members.
May participate in capabilities presentations.
Qualifications:
Bachelor’s Degree, preferably in life science or nursing; or equivalent
>5 years of independent on-site monitoring experience and at least 1 year experience as an unmasked monitor is required.
At least 1 year Ophthalmology, ideally within a retina indication (i.e. Age-related Macular Degeneration, Diabetic Macular Edema, Geographic Atrophy, RVO, BRVO, CRVO, etc.), experience is preferred.
Able to work in a fast-paced environment with changing priorities.
Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
Possess the understanding of Good Clinical Practice regulations, ICH guidelines.
Ability to work independently as well as in a team matrix organization.
Excellent written and verbal communication skills
Fluent in English and local language
Excellent organizational skills
Technology savvy and good software and computer skills
Soft skills requirements: Self-awareness, resolute, flexibility, collaborative mindset, proactivity, analytic approach, and attention to detail, coach ability, motivated to take on new challenges, facilitation of discussion, diplomacy in difficult situations.
Ability to take the ownership of the assigned tasks.
Ability to manage complex or early phases studies.
Ability and willingness to travel up to 60-80%, overnight and abroad, if applicable.
What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.
Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.
#Together we make a difference
Company
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